(415 days)
Specific indications: used to apply an electrical current to electrodes on patient's skin at some limited ● positions to function as:
- Relaxation of muscle spasms;
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion.
Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for . the treatment of medical diseases and conditions.
Home Care various models of Powered Muscle Stimulator, HT-329M1, HT-329M2, HT-329M3, and HT-329M4
The provided text is a 510(k) premarket notification letter from the FDA. It does not contain information about acceptance criteria or a study proving device performance. This document is a regulatory approval notice, indicating that the Home Care Powered Muscle Stimulator (various models) is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC results from this document.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its body and wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird.
Public Health Service
OCT 2 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Home Care Technology Co., Ltd. c/o Ms. Shu-Chen Cheng ROC Chinese-European Industrial Research Society 2064 Tamarin Drive Columbus, OH 43235
Re: K023000
Trade/Device Name: Home Care various models of Powered Muscle Stimulator, HT-329M1, HT-329M2, HT-329M3, and HT-329M4 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: July 26, 2003 Received: July 31, 2003
Dear Ms. Cheng:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Ms. Shu-Chen Cheng
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
R. Mark A. Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Applicant :
510/k) Number:
Device Name : Home Care various models of Powered Muscle Stimulator,
HT-329M1, HT-329M2, HT-329M3, and HT-329M4
Indications for Use :
- Specific indications: used to apply an electrical current to electrodes on patient's skin at some limited ● positions to function as:
- Relaxation of muscle spasms;
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion.
- Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for . the treatment of medical diseases and conditions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use
Per 21 CFR 801.109
OR
Over-The-Counter (Optional Format 1-2-96)
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).